[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
BALANCING ACT: THE HEALTH ADVANTAGES OF NATURALLY-OCCURRING HORMONES IN
HORMONE REPLACEMENT THERAPY
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
JULY 22, 2004
__________
Serial No. 108-249
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia C.A. ``DUTCH'' RUPPERSBERGER,
CANDICE S. MILLER, Michigan Maryland
TIM MURPHY, Pennsylvania ELEANOR HOLMES NORTON, District of
MICHAEL R. TURNER, Ohio Columbia
JOHN R. CARTER, Texas JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee BETTY McCOLLUM, Minnesota
PATRICK J. TIBERI, Ohio ------
KATHERINE HARRIS, Florida BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnet, Minority Chief of Staff/Chief Counsel
Subcommittee on Human Rights and Wellness
DAN BURTON, Indiana, Chairman
CHRIS CANNON, Utah DIANE E. WATSON, California
CHRISTOPHER SHAYS, Connecticut BERNARD SANDERS, Vermont
ILEANA ROS-LEHTINEN, Florida (Independent)
ELIJAH E. CUMMINGS, Maryland
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
Mark Walker, Chief of Staff
Mindi Walker, Professional Staff Member
Danielle Perraut, Clerk
Richard Butcher, Minority Professional Staff Member
C O N T E N T S
----------
Page
Hearing held on July 22, 2004.................................... 1
Statement of:
Alving, Barbara, M.D., Acting Director, National Heart, Lung,
and Blood Institute, National Institutes of Health, U.S.
Department of Health and Human Services.................... 10
Fugh-Berman, Adriane, M.D., associate professor, Department
of Physiology and Biophysics, Georgetown University School
of Medicine; David Brownstein, M.D., Center for Holistic
Medicine; Carol Petersen, managing pharmacist, Women's
International Pharmacy; Vicki Reynolds, owner, Texas
Reliant Air-Conditioning and Heating, Inc.; and Steven F.
Hotze, M.D., Hotze Health and Wellness Center.............. 29
Letters, statements, etc., submitted for the record by:
Alving, Barbara, M.D., Acting Director, National Heart, Lung,
and Blood Institute, National Institutes of Health, U.S.
Department of Health and Human Services, prepared statement
of......................................................... 14
Brownstein, David, M.D., Center for Holistic Medicine,
prepared statement of...................................... 41
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 5
Fugh-Berman, Adriane, M.D., associate professor, Department
of Physiology and Biophysics, Georgetown University School
of Medicine, prepared statement of......................... 32
Hotze, Steven F., M.D., Hotze Health and Wellness Center,
prepared statement of...................................... 69
Petersen, Carol, managing pharmacist, Women's International
Pharmacy, prepared statement of............................ 57
Reynolds, Vicki, owner, Texas Reliant Air-Conditioning and
Heating, Inc., prepared statement of....................... 62
BALANCING ACT: THE HEALTH ADVANTAGES OF NATURALLY-OCCURRING HORMONES IN
HORMONE REPLACEMENT THERAPY
----------
THURSDAY, JULY 22, 2004
House of Representatives,
Subcommittee on Human Rights and Wellness,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:30 p.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the subcommittee) presiding.
Present: Representatives Burton and Watson.
Staff present: Mark Walker, chief of staff; Mindi Walker,
Brian Fauls, and Dan Getz, professional staff members; Nick
Mutton, press secretary; Danielle Perraut, clerk; Sarah
Despres, minority counsel; Richard Butcher, minority
professional staff member; and Cecelia Morton, minority office
manager.
Mr. Burton. First of all, I want to apologize for my
tardiness. We were supposed to start at 2:30, but we've had a
very involved, contentious hearing down in the committee room.
And I've learned something after 22 years, and that is that the
last week of the session before we go out on the August break,
you shouldn't have a hearing. Because it's absolutely a
madhouse around here. We've got a lot of votes and a lot of
things going on.
Good afternoon. A quorum being present, the Subcommittee on
Human Rights and Wellness will come to order.
I ask unanimous consent that all Members and witnesses'
written and opening statements be included in the record.
Without objection, so ordered.
I ask unanimous consent that all articles, exhibits and
extraneous or tabular materials referred to be included in the
record, and without objection, so ordered.
And in the event that other Members attend the hearing that
are not on the committee, I ask unanimous consent that they be
permitted to serve as a member of the subcommittee for today's
hearing. And without objection, so ordered.
We're convening today to examine the health benefits of
using natural hormones in hormone replacement therapy.
As you might know, millions of American women are
prescribed synthetic hormones by their doctors to assist with
the decreasing levels of estrogen and progesterone in their
bodies experienced during menopause as well as other hormonal
fluctuations that might occur. It might be surprising to note
that many men in the United States are administered
testosterone for similar decreases in hormonal levels during
the aging process, which progresses at a similar rate as
menopause, called andropause.
While the declining concentrations of hormones in the body
is entirely normal, hormone replacement therapy should not be
undervalued as a highly effective medical treatment. It not
only balances the hormone level within a patient, but it also
serves as a preventative measure to ward off potential health
risks associated with imbalanced hormones such as osteoporosis
and the No. 1 cause of death in the United States, heart
disease.
Because naturally occurring substances cannot be patented
in the United States, pharmaceutical companies must somehow
manipulate hormones with additional chemicals in order to be
able to hold the manufacturing rights of these formulas.
Since pharmaceutical companies must mass produce these
synthetic hormones according to the formulations covered by a
patent, they are only offered in certain doses as a ``one size
fits all'' solution to hormonal imbalances. This results in
many American women and men being administered either too much
or too little of the hormones they need to properly address
their wellness needs, thus creating the potential for further
health complications.
Even more concerning is the nature of the synthetic
hormones. Because natural hormones must be manipulated by
chemicals in order to be patented, the body does not recognize
some of the components of the synthetic hormones, which causes
some serious and potentially life-threatening side effects.
In 1991, the National Institutes of Health [NIH], launched
the ``Women's Health Initiative,'' one of the largest studies
on hormone replacement therapy ever initiated in the United
States. This clinical trial observed 16,608 postmenopausal
women who received estrogen and progestin therapy or a placebo,
as well as 10,739 women who had a hysterectomy and were given
estrogen alone or a placebo. This study was supposed to
continue until 2005; however, it was ceased in July 2002
because the NIH's Data and Safety Monitoring Board found an
increased risk of breast cancer, heart attacks, strokes and
total blood clots.
This information is especially sobering to me, as it has
devastated my family forever. Barbara, my wife, was taking
synthetic hormones when she contracted breast cancer that
eventually, at least in part, took her life. And I firmly
believe that her overall health and quality of life
deteriorated because she was taking those doctor-prescribed
hormones. Of course, at the time, we didn't know that.
There is an alternative to the mass produced and chemically
altered hormones, and these are called biologically identical
or natural hormones. Essentially, there are entities known as
compounding pharmacies that are smaller scale operations to
pharmaceutical companies that produce medicines more
specialized to accommodate a wide variety of patients, rather
than the one size fits all approach to manufacturing hormones.
These compounding pharmacies are located around the country
and have the capacity to concoct natural, plant-based hormone
medications for use in hormone replacement therapy. Because
these biologically identical hormones are the same chemical
structure as the hormones created in the body, the body does
not have the same harmful reactions as it does when the
synthetic hormones are administered.
To better explain the health benefits of naturally
occurring hormones, as well as the operation of compounding
pharmacies, the subcommittee will have the pleasure of hearing
from Dr. Steven Hotze, a physician and founder of the Hotze
Health and Wellness Center located in Houston, TX. Dr. Hotze's
practice specializes in using biologically identical hormones
to assist both men and women correct hormonal imbalances. To
gain a better perspective into the benefits of natural hormones
in hormone replacement therapy, Ms. Vicki Reynolds, a patient
of Dr. Hotze's, is here with us today to share her personal
experience.
In addition, the subcommittee will hear testimony from Ms.
Carol Petersen with the Women's International Pharmacy, to
discuss the operations of compounding pharmacies in the United
States.
Dr. David Brownstein is with us as well to discuss the
further benefits of using natural hormonal therapy to combat
hypothyroidism. Dr. Brownstein has written a number of books on
this subject and is considered one of the foremost experts in
the field of holistic medicine. The doctor also serves as the
medical director at the Center for Holistic Medicine.
While many physicians believe that administering their
patients hormones, whether synthetic or natural, is a
beneficial tool to assist with hormonal transitions, there are
some doctors who contend that scientific literature shows that
these tactics are not necessarily the healthiest option for
patients. In order to explain this viewpoint, the subcommittee
will hear testimony from Dr. Adriane Fugh-Berman, an associate
professor with the Department of Physiology and Biophysics at
Georgetown University. Dr. Fugh-Berman is internationally known
as an expert in the scientific evaluation of alternative
medicine, as well as nationally recognized expert on the topic
of women's health.
The U.S. Federal Government has produced many studies and
has approved various drugs to assist in hormone replacement
therapy. The subcommittee has the distinct pleasure of hearing
from Dr. Barbara Alving, who is married to a Hoosier, is that
what you told me?
Dr. Alving. No, I'm the Hoosier.
Mr. Burton. You're the Hoosier? Where are you from?
Dr. Alving. Fort Wayne, IN.
Mr. Burton. That's right on the edge of my district, so God
bless you, my child. [Laughter.]
Dr. Alving. My brother lives in Indianapolis.
Mr. Burton. What part?
Dr. Alving. The south part.
Mr. Burton. Oh, well, he may not be able to vote for me, so
I'll have to pass on him. [Laughter.]
She's the Acting Director of the National Heart, Lung and
Blood Institute at the Department of HHS, and she will give an
overview of the Department's activities in regard to this
issue.
I look forward to hearing from all of you today. And once
again, since we started late, we'll get started right away with
you, Dr. Alving. We appreciate your being here.
[The prepared statement of Hon. Dan Burton follows:]
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STATEMENT OF BARBARA ALVING, M.D., ACTING DIRECTOR, NATIONAL
HEART, LUNG, AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF
HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Alving. Thank you, Mr. Chairman. I'm pleased to appear
before this committee in my capacity not only as the Acting
Director of the National Heart, Lung and Blood Institute, but
also Director of the NIH's Women's Health Initiative. I have
been the Director of this since 2002. This was after the first
paper was released on the role of Prempro in protection against
heart disease. The Women's Health Initiative, however, has been
administered by my institute since 1997.
So I'm first here to tell you what we've learned from the
WHI, with regard to hormone therapy, using conjugated equine
estrogen, and second, to comment on alternative therapies that
are now receiving attention. The WHI began in 1991 and the
purpose was to really investigate approaches that might be
helpful to older women in preventing common chronic diseases,
particularly coronary heart disease and also to determine if
this would increase the risk for breast cancer, alter the risk
for colorectal cancers and have an effect on osteoporosis.
Estrogen replacement was just one such approach. For much
of the 20th century, popular thinking was that restoring the
levels of estrogen which ebb during middle age would enable
women to remain forever young. And we're still trying on that
end. Although estrogen was initially prescribed to alleviate
troublesome menopausal symptoms, a number of observational or
epidemiologic studies really suggested that women who took
estrogen experienced a lower incidence of chronic diseases,
particularly heart disease, and enjoyed better health overall
than women who did not take prolonged hormone therapy. And data
from many basic science investigations really provided
explanations for how this might occur.
But we really didn't have actual proof that this was the
case. So in 1991, a very bold woman, Dr. Bernadine Healy, said
it's time to really initiate a very large scale study. So the
Women's Health Initiative hormone trial was designed to answer
these questions. And remember, this was before the era of
statins and other therapies that have been widely accepted in
this current era.
So as you've said, the Women's Health Initiative recruited
about 27,000 healthy postmenopausal women of 50 to 79 years of
age. This age group was recruited because this is the age at
which one would begin to see cardiovascular events and other
adverse effects. And these women were divided into one of two
groups, depending on whether or not they had undergone a
hysterectomy. Those who still had a uterus were assigned to
take a pill containing estrogen and progestin. This was 0.625
milligrams of conjugated equine estrogen, plus 2.5 milligrams
of medroxyprogesterone acetate, also known as Prempro, or a
placebo. And those who had undergone a hysterectomy took
Premarin, 0.625 milligrams of conjugated equine estrogen or a
placebo.
And you may say, well, why those drugs? Why those doses?
These drugs were the most widely used at this time in the
United States. So it was decided that not all doses and not all
different combinations could be studied. So this was the one
that was accepted for study.
It's worth noting that there was a lot of controversy at
the beginning of this trial. Many interested parties said the
trial should not be done, it's obvious that hormone therapy is
beneficial, it's a foregone conclusion. Some even said it was
not ethical to do, because it would take half of the
participating women to take placebos and thereby deny them the
positive effect of hormones.
Nonetheless, the arguments in favor of a randomized placebo
controlled clinical trial prevailed, so now as we know, we've
seen results. The WHI trial of estrogen plus progestin was
halted in 2002, as you have said, Mr. Chairman, after an
average followup of 5.2 years. Compared with women who took a
placebo, women taking the hormones of Prempro or estrogen plus
progestin experienced an increased risk of breast cancer and
more episodes of heart attacks, strokes and blood clots.
However, they also had lower rates of colo-rectal cancer and
fractures. But it was felt that overall, this did not merit
using this drug as protection against chronic disease.
And furthermore, an ancillary study, that is a study that
really hadn't been included in the beginning but was sort of
added on, well, which actually was funded by the manufacturer,
Wyeth funded this study initially in women 65 years and older
who were in this study were tested for cognitive effects of
Prempro. Surprisingly enough, it was found that in these older
women, there was an increased risk of dementia and no really
improvement of cognitive impairment with the taking of Prempro.
This too was a very big surprise because there had been papers
suggesting that Prempro could actually be protective against
cognitive impairment.
Subsequently, in the spring of 2004, the estrogen alone
trial, which the DSMB, or Data Safety Modern Board have said
should be continued was halted, because the NIH, on looking
over all of the data and in listening to the DSMB, felt that
there was really no effect on coronary heart disease, that is,
there was no benefit or risk but there was a continued
increased risk for stroke. What was also interesting with the
estrogen alone study was that there did not appear to be any
increased risk for breast cancer during the time of this study.
There was, however, an increased risk of deep venous
thrombosis, and there was a reduced risk of hip and other
fractures.
And again, finding from the cognitive study in women taking
estrogen alone revealed that really, estrogen did not reduce
the incidence of dementia and really did not have any
improvement, in fact had an adverse effect on cognitive
function.
So in light of the WHI findings and the findings from the
dementia studies, the Food and Drug Administration provided the
following update in April 2004. Estrogens and progestins should
not be used to prevent chronic diseases, such as memory loss,
heart disease, heart attacks or stroke. Estrogens provide
valuable therapy for many women for menopausal hot flashes. But
they do carry risks. And therefore, menopausal women who are
considering using estrogen or estrogen with progestin should
discuss with their physicians the benefits versus risks and for
hot flashes and significant symptoms of vulvar and vaginal
atrophy, the products are approved and effective therapies.
There are also approved for women whose significant risk of
osteoporosis outweighs the potential adverse effects and if
they cannot other drugs that are approved for postmenopausal
osteoporosis. And then the FDA said, estrogens and progestins
should be used, when they're used, at the lowest doses for the
shortest duration to reach treatment goals. Although we do not
know at what dose there may be a less risk of serious side
effects and that women indeed are encouraged to talk to their
health care provider regularly about their ongoing treatment.
There's also in women who take hormone therapy a higher
incidence of abnormal mammograms which require medical
attention and really need to be evaluated in greater detail
when those abnormalities do occur. Therefore, each woman's
individual medical situation needs to be carefully discussed
with her health care provider to make the best decisions.
Now, for prescription hormone formulations other than those
studied in the WHI, the FDA advises, although other estrogens
and progestins were not studied, it's important to tell
postmenopausal women who take hormone therapy about the
potential risks which are assumed to be the same for other
products, and they have put these labels on those products.
In the aftermath of the Women's Health Initiative finding,
increased attention has been focused on the use of
complementary and alternative medicine to manage symptoms
associated with the menopausal transition. This includes
dietary supplements, botanicals, which are probably the most
commonly used. The National Center for Complementary and
Alternative Medicine supports both basic and clinical research
on the safety and efficacy of botanicals such as soy, black
cohosh and red clover in alleviating hot flashes, osteoporosis
and cognitive and affective problems.
Other studies are generating laboratory data that are vital
to the understanding of the mechanism of action and
characterizing these botanicals to identify the active
ingredients in the botanicals so that standardized supplements
can be prepared. For example, two ongoing basic studies are
looking at the effect of black cohosh extract on human breast
tissue and its role as a serotonin modulator and other research
is looking at the effect of soy on breast and endometrial
tissue, as well as on bone. In addition to individual research
project grants, the National Center for Complementary and
Alternative Medicine supports several research centers on
women's health.
The National Institute of Aging is supporting a 4-year
randomized control trial to evaluate the efficacy and safety of
phytoestrogen based approaches, such as black cohosh and multi-
botanical preparations given with and without soy diet
counseling for treating vasomotor symptoms in premenopausal and
in postmenopausal women. The toxicity of black cohosh and other
herbals and phytoestrogens is being evaluated by the National
Institute of Environmental Health Sciences as a part of an
overall effect to establish the safety of herbal medicines.
The scientific literature on complementary and alternative
medicines is equivocal, due to problems of very small trials,
short duration of treatment, very large placebo effects and
very imprecise measures for measuring hot flashes.
Investigations of the efficacy of soy to treat cognitive
changes has produced conflicting results. Now, the NCCAM,
National Center for Complementary and Alternative Medicine, has
contracted with the Agency for Health Care Research and Quality
to conduct and review and to assess the literature to provide a
clearer idea of what is known about soy.
Clearly, additional research will be needed to provide the
safety and efficacy of the information on the range of these
alternative modalities. And the NIH is working with other
institutes all together in this area, as well as with the FDA
and the women's health component of the Department of Health
and Human Services. Also, there are studies on assessing hot
flashes, what is the biology behind the hot flashes and in
March 2005, the NCCAM, National Institute of Aging and other
institutes will co-sponsor a state of the science meeting on
the management of menopausal related symptoms.
So women are eagerly awaiting the outcome of Federal
efforts to uncover new approaches to address the menopausal
symptoms. And in discussions with gynecologists, we know that
women also are seeking natural or biologically identical
hormone therapies via entities such as the Women's Health
International Pharmacy. In addition, the FDA has been very
proactive in the approval of additional hormone therapy since
the ending of the Women's Health Initiative. For example, lower
doses of Premarin are now available as well as Prempro. And
most recently, a drug known as Menotestam has just been
approved by the FDA. This is an estrogen patch.
So some of what the FDA has approved is biologically
identical and other components are not. I thought that all of
this was very well laid out on the Web site of the Women's
International Pharmacy.
So I thank you for the opportunity to address you, and I'd
be pleased to answer any questions.
[The prepared statement of Dr. Alving follows:]
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Mr. Burton. Thank you very much.
I heard you mention there were studies on dementia.
Dr. Alving. Yes.
Mr. Burton. Who conducted those studies? Was that the FDA?
Dr. Alving. No. The investigators in the Women's Health
Initiative conducted those studies.
Mr. Burton. What company sponsored those studies?
Dr. Alving. Actually, one of the principal investigators
received funding from Wyeth to do----
Mr. Burton. OK, that's all I wanted to know. A
pharmaceutical company. That's all I wanted to know.
Dr. Alving. However, they switched the funding after that.
Mr. Burton. I know. Did you know, Doctor, that they've been
putting mercury in vaccines, which is another subject----
Dr. Alving. Yes.
Mr. Burton [continuing]. Since 1929. Do you know the FDA
has never tested it, ever? And yet our kids are getting up to
26 vaccinations before they start to school? And they've been
containing mercury, and we've gone from 1 in 10,000 children
that were autistic to 1 in 166? An absolutely epidemic. And the
FDA never really tested it.
What I'd like to know about estrogen is, why did it take so
long to do these tests? They've been giving synthetic estrogen
for how many years?
Dr. Alving. I think they were probably developed, maybe in
the last, about 40, 45 years old.
Mr. Burton. Did the FDA test those?
Dr. Alving. In terms of tests such as the Women's Health
Initiative?
Mr. Burton. Yes.
Dr. Alving. They did not. And I think really the only----
Mr. Burton. You don't need to go into detail. They didn't
do it?
Dr. Alving. As far as I know, they did not.
Mr. Burton. And they just conducted a test in 1991?
Dr. Alving. They started it in 1991.
Mr. Burton. And the tests showed that the people who had
the estrogen had higher rates of heart disease and what else
was it?
Dr. Alving. Well, if you look at Prempro or estrogen plus
progestin, it was a higher rate of heart disease and breast
cancer and stroke, blood count.
Mr. Burton. This they found after 40 years?
Dr. Alving. Five years.
Mr. Burton. But they've been using it for 35 or 40 years?
Dr. Alving. Yes.
Mr. Burton. What do we pay those people for over there? I'm
not being facetious. I mean, because they're getting billions
and billions and billions of dollars and they are still putting
mercury in almost every vaccination for adults and we have a
tremendous increase in Alzheimer's. My grandson got autism
after getting nine shots in 1 day, seven of which contained
mercury. We've got an epidemic in that. And now we're finding
out that the synthetic estrogen caused problems probably more
than it helped.
Now, you said they've gone to lower doses of some of these
estrogen products, right? Those are still the synthetics,
aren't they?
Dr. Alving. Yes, lower doses have been approved by the FDA.
Mr. Burton. OK, they've been approved. Have they tested
those lower doses?
Dr. Alving. No.
Mr. Burton. Oh, my God. Do you mean to tell me they had a
test, then went 5 years, and it showed that people were getting
sicker by using the stuff, and so they went to lower doses?
Why? If it's causing more problems than it's solving, why not
take it off the market until they do all the testing? Until
they test lower doses, higher doses, middle doses? It makes no
sense.
Do you know why they didn't? I want to tell you why they
didn't. I know why. Because the pharmaceutical companies would
lose a lot of money. Just like they would lose a lot of money
if they took mercury out of all the vaccines.
Do you know, and I want you to hear all this, because I
want you to take it back to FDA and HHS. The NIH, I think it
was, just completed a study saying that the mercury in
children's vaccines and adult vaccines really didn't cause any
problems. One of the principal studies that they cited was from
Denmark. And the company in Denmark that did the study
manufactures thimerosal, which is 50 percent mercury, and they
sell it into the United States.
Would you say they have a conflict of interest? Hell, I
would think so.
Anyhow, the NIH and HHS and the other agencies over there
are too tied to the pharmaceutical industry and it's going to
come up and bite them in the butt one of these days. It really
is. Because the American people are finding this out.
Now, why in the world they're going with lower doses of a
product that caused women's problems like high blood pressure,
heart attacks, whatever else you mentioned there, I don't have
it all in front of me right now, why in the world they would
even continue to do that instead of taking it off the market
until it's properly tested boggles my mind. And the only
conclusion you can come to is the pharmaceutical companies
would take a hit. And they don't want to do that. They just
don't want to do that.
Can you give me another answer?
Dr. Alving. Yes.
Mr. Burton. What's the other answer? I'd like to hear it.
Dr. Alving. I think you make some very good points. I think
what women want hormone therapy for most, if you ask any woman
of a certain age in this room, is for hot flashes, for the
symptoms of menopause.
Mr. Burton. Well, I date some women about your age, and I
want to tell you, they take them for other reasons, too.
[Laughter.]
Dr. Alving. And so, I think that what the, we are unable to
really, we'd have to wait another 5, 10 years go get the answer
on these hormones. So what has been asked in the meantime is to
take the lowest dose for the shortest period of time, and the
FDA has put this type of branding and warning on every product,
whether it's bioidentical or not.
Mr. Burton. But these are still the synthetic hormones, are
they not?
Dr. Alving. No, they put the branding also on the
bioidenticals.
Mr. Burton. Oh. Well, you said that the FDA was evaluating
the safety of herbal medicines now, didn't you?
Dr. Alving. I said the NIH, because the FDA has not
approved any herbal medicines. It is not under FDA approval.
They do not regulate them.
Mr. Burton. Does the FDA have to approve herbals?
Dr. Alving. No, they don't.
Mr. Burton. But they do have to approve the synthetics?
Dr. Alving. Well, anything that is made by a drug company,
yes.
Mr. Burton. So the synthetics that have been causing all
these health side effects, they have to approve but they never
tested until just recently. And the herbals, I noticed the way
you phrased that, you said that HHS is looking at the safety of
the herbal medicines.
Why didn't they look at the safety of the biologically
altered medicines that they've been prescribing for years,
doctors have? I wonder why they didn't do that earlier?
Dr. Alving. That would be in the province of the NIH to
conduct the clinical trials. And I think that this was then
started in 1991, and as I've told you even then it was
considered to be a very brave undertaking.
Mr. Burton. In 1991?
Dr. Alving. Yes.
Mr. Burton. But the women who didn't take the hormones,
synthetic hormones, did better over all the ones that didn't?
Dr. Alving. That's correct.
Mr. Burton. Oh, man.
Dr. Alving. Well, it all depends on what you're talking
about.
Mr. Burton. Let's just look at overall health.
Dr. Alving. Overall, I would say yes, that's why the trial
was stopped.
Mr. Burton. Yes, they did a lot better if they didn't take
the synthetics.
Dr. Alving. Absolutely. And that's why the trial was
stopped.
Mr. Burton. And synthetics have been used for 40 some
years, approximately.
Dr. Alving. Yes.
Mr. Burton. And they started testing them 10 years ago?
Dr. Alving. Yes.
Mr. Burton. And HHS and FDA let that happen. What are we
paying them for over there? I just don't understand it.
I still can't understand why they went to lower doses of a
product that was causing all of these health side effects. I
just can't understand it. Do they know? Does HHS and FDA and
our health agencies, do they know that the smaller doses won't
produce the same side effects?
Dr. Alving. They do not know that.
Mr. Burton. Then why do they do it?
Dr. Alving. Because what they've also done, what they have
seen is that these side effects occur over a period of time.
And that's why they have said, in the absence of knowing, we
are going to tell all women about these risks at whatever dose,
even though we don't know if it's safer or better, but we're
going to let them know the risks and we're going to say, use it
the shortest period of time at the lowest possible dose.
Mr. Burton. You know, in a perfect world, every doctor in
the country, in the world, would know what the HHS and FDA are
saying should be done. But they don't. They don't read all the
circulars and they don't see all this stuff. When my wife was
dying of cancer, I talked to doctors about the things that were
talked about in medical journals and they didn't know anything
about it. We changed doctors, but it was too late, she died
anyhow.
But it just boggles my mind that you would go on with lower
doses of a substance that's caused all these problems when you
know that they cause severe side effects and you knew that
women that didn't even take the stuff did better health-wise,
so you go to lower doses. Then the doctors back at my hometown
and elsewhere are supposed to understand all this when they've
been out of medical school for 10, 15 years. I just don't get
it.
And I don't understand why they haven't done studies on the
herbals right now. Why hasn't HHS conducted a study on
biological hormones, bioidentical hormones? If they did a study
on the synthetics, why didn't they do it on those?
Dr. Alving. I think the reason that they chose, as I said,
that dose and that particular drug at that particular time in
1991 was that is what the majority of American women who were
taking hormone therapy were taking.
Mr. Burton. Well, this is 2004.
Dr. Alving. Yes, and times have changed.
Mr. Burton. That was 13 years ago.
Dr. Alving. I know. Times have changed.
Mr. Burton. Why haven't they started testing on these
bioidentical hormones that aren't from pigs and cows and all
this other stuff?
Dr. Alving. I think if the funding were available----
Mr. Burton. If the funding--do you know how much money we
give you guys over there? Do you have any idea? We give you
billions and billions and billions and every year you want
more. And we've got women who are getting sicker than a dog and
some probably dying from something that was never tested. And
then what you say after you find out that the stuff that you
were putting in their bodies was causing more problems than if
they didn't take it at all, you say, oh, we're going to go back
and we're going to just cut the doses, instead of saying, why
not just get off of it or go on these bioidentical hormones, or
at least study them? And you haven't even started to study on
them, have you, the bioidentical hormones?
Dr. Alving. They have not started any long terms studies in
terms of women's health as an issue.
Mr. Burton. Have you started any short term studies?
Dr. Alving. The bioidenticals that have received FDA
approval have undergone short term studies.
Mr. Burton. What do they show?
Dr. Alving. They are looking for efficacy against hot
flashes and any adverse effects that could be picked up on a
short term study.
Mr. Burton. I see. Are they showing any side effects at all
like the long term study that we showed with the synthetics?
Dr. Alving. Not that I am aware of. And that would be for
the labeling of the FDA.
Mr. Burton. If they did a short term study, why didn't they
decide to go on with a long term study? If the short term study
was beneficial, why not go with a long term study to find out
their side effects?
Dr. Alving. I think one of the issues is that of cost and
duration. One would have to continue such a study for about 10
years----
Mr. Burton. Well, if you did it with synthetics and you
knew it didn't work and it cost a lot of money to do that
study, why wouldn't you say, OK, we're going to spend a like
amount on the bioidentical hormones? Why?
Dr. Alving. May I say why?
Mr. Burton. Yes, I'd like to know. I think I know why. It's
because the pharmaceutical companies won't make any money off
of it.
Dr. Alving. What I would say is that what it appears is
that the reason one would take hormones long term is to prevent
chronic diseases. Most women take hormone therapy for about 5
years or less. And they take it for menopausal symptoms. Since
this study was started in 1991, newer drugs have come out. For
example, we have other drugs that will protect against
osteoporosis.
Mr. Burton. Are they synthetics?
Dr. Alving. I'm talking about other drugs against
osteoporosis, the bisphosphonates, for example. We have other
drugs for heart disease, statins.
Mr. Burton. Have those been tested, the ones that you're
talking about that just came out?
Dr. Alving. Well, yes. In terms of risks and benefits, and
all of them have----
Mr. Burton. No, no, no. Have they had any long term tests
with placebos and all that?
Dr. Alving. As long term as the FDA requires.
Mr. Burton. And how long is that?
Dr. Alving. I think, I am going to say at least 3 to 4 to
up to 10 years. I would have to go back and look at that
literature to get the specific literature.
So what I'm trying to say is that there has been a changing
of the landscape in terms of the drug therapies. Some women
don't even want to take hormone therapy at all----
Mr. Burton. I wouldn't either.
Dr. Alving [continuing]. And don't have hot flashes.
Mr. Burton. You say they've got these for men. There ain't
no way, Jose, I'm going to take that stuff. You guys over there
are using human beings as guinea pigs without testing them.
You're a lovely lady, but this, it really isn't right. It isn't
right to run a study after 40 years or 30 years and then find
out that the people who are taking the medicine that the
pharmaceutical companies are producing are doing worse than the
ones that aren't taking it. Then what you say instead of
stopping it is, OK, we're going to go to lower doses.
That's like saying, OK, one bullet won't kill you, so we'll
cut it in two and just use half a bullet.
Dr. Alving. It will half kill you.
Mr. Burton. Yes, it will half kill you. Let me ask you
this. Is the National Center for Complementary and Alternative
Medicine looking at bioidentical hormones as a possible
recommendation for FDA to suggest to women? Are they looking at
that right now?
Dr. Alving. They are not looking at that to my knowledge.
Mr. Burton. Why? Why?
Dr. Alving. Because they are centered on the other
alternatives that are undergoing study that I mentioned.
Mr. Burton. And the other alternatives are?
Dr. Alving. As I mentioned, black cohosh and the
flavonoids, phytoestrogens, other things such as that.
Mr. Burton. Are those natural hormones?
Dr. Alving. They're natural agents, in that you can buy
black cohosh, it's extracted. Now, you don't know what else is
in there, because it's not regulated by the FDA.
Mr. Burton. Well, you know what, I really would want the
one that's approved by the FDA because it would only kill me.
[Laughter.]
And I don't mean to be facetious, but since my grandson
became autistic, I started checking into the things that FDA is
putting on the market and the conflicts of interest that have
taken place by some of the advisory committees over there who
have an interest in pharmaceutical stocks that are making the
decisions on this stuff. There's too much money and too much
complicity between the pharmaceutical companies and our health
agencies.
And if you've got a study that shows that women are getting
more heart disease, for instance, from taking these synthetic
hormones than a woman who doesn't take any, that would lead you
to believe they're better off not taking it. Wouldn't that lead
you to believe you're better off not taking it?
Dr. Alving. But I would make another----
Mr. Burton. You can answer in just a second. And if that
conclusion is accurate, why would you say, OK, we're going to
cut the dose in half and you just take half the poison? Why?
Dr. Alving. In the Women's Health Initiative, the women who
were enrolled in the studies were between 50 and 79 years. The
mean age was 63 years. In fact, it's been very highly
criticized for that. When you do a study, as you can see, you
get criticism from all sides.
So one of the critics, a big criticism of this, you started
this in women whose mean age is 63 years old. That's not who
has hot flashes. Well, this was not a hot flash study.
Currently, the FDA guidelines, and I don't work for the FDA, I
work for NIH, are that these drugs are to be used for treatment
of menopausal symptoms. And about the average age of women
having menopausal symptoms is around 45 to 50. So you're
getting a different age range.
Mr. Burton. I hear you. I'm going to yield to Ms. Watson,
but let me just say one more thing in conclusion. That is when
my wife got breast cancer, and she took those damned hormones
for years, those synthetics, we found, when we went to buy
furniture, went to buy groceries, an absolute plethora of women
who were having breast cancer problems. It is an epidemic.
Women don't talk about it to people like me, but they'll talk
about it to another woman who's experiencing breast cancer.
And I want you to know, it's an epidemic. It's absolutely a
sin. It's a sin. It's an absolute sin for our Government to
approve things that we're putting into human bodies, especially
women, of age 30, 50, 100 that hasn't been properly tested. And
you say they don't have enough money over there. They have
enough money. It's just where they set their priorities. And if
they find out that the synthetic estrogen is causing women to
have severe heart trouble and other problems, and the women who
don't take it are doing much, much better, then why in the
world would they not take it off the market?
And the reason is the same reason that they haven't taken
mercury out of vaccines. Mercury is one of the most toxic
substances on the face of the Earth. When we had a spill in my
district, they brought in people who looked like they were from
outer space, in uniforms, to clean up a spill of this much. And
they evacuated the neighborhood. And yet we're putting it into
our kids' bodies, into your body, if you got a flu shot or a
tetanus shot or anything else right now. And it's one of the
contributing factors, according to scientists around the world,
of autism and other neurological diseases, like Alzheimer's.
Yet the FDA continues to let it be on the market. And at
the same time, they're doing the same thing with estrogen, only
in lower doses. And it is absolutely criminal. And that's being
subsidized by me and you and the taxpayers, and nobody's doing
a doggone thing about it. And it really bothers me.
And you're a lovely lady, but we've got a problem.
Go ahead, Ms. Watson.
Ms. Watson. I want to thank Mr. Chairman for his passion,
his interest, his concern. And we work together as a team. We
both have an aversion to using these toxic substances in
medication that's ingested by humans, and so I've always looked
for a biological, natural kind of alternative.
If you don't get anything else out of these hearings, Madam
Colonel, just know that there is a directive to ask NIH and WHI
to start research that will include the biological identical
hormones. We are finding from casual information coming in that
they are far more healthful and they have a far more beneficial
way of treating. Because they're done on an individual basis.
Dr. Alving. Yes.
Ms. Watson. And not everything works for everyone.
Dr. Alving. I understand that.
Ms. Watson. So I wish that you would go back as an emissary
of this approach. The women of the world will thank you,
particularly the women here. And I as a woman definitely am
going to push this with my partner here, who, and I don't have
to explain to you how deeply he feels about this, I think
you've been hearing it for quite a few minutes. And we're going
to work as a team to be sure that we take the toxic substances
out of the environment.
My big thing right now is mercury. We're trying to get
mercury out of dental amalgams and we're being fought by the
dental community. And they say, well, it's sealed and so on.
But you crack a tooth, vapors come up.
So we have to change the thinking. We have to change the
culture. And I hope that now that we're in a new millennium,
the FDA can follow behind us a little bit in changing the
culture. We certainly are going to be working toward that. And
thank you, Mr. Chair. I'm going to zip to the floor.
Mr. Burton. Well, Doctor, thank you very much. We didn't
mean to abuse you. But the one thing I try to do when we have
witnesses from HHS and our health agencies, FDA, is to try to
impress upon them the strong feelings that we have in the
Congress. And it's not just me. We've had a number of votes on
the floor on reimportation and other things where the
pharmaceutical companies are concerned. And they've been
surprising in that the representatives of the people realize
what's going on.
I want to continue to give you guys billions of dollars. I
really do. I think we have the highest quality and standard of
life and health of any country on the face of the Earth,
because we have good health agencies. But they drop the ball
too many times. And they're allowing the pharmaceutical
industry to have too much influence.
I want the pharmaceutical industry to make a lot of money.
But I don't want them to do it at the expense of people because
we haven't tested these things properly. And I hope that you'll
look at these complementary medical procedures, the hormones,
the natural hormones we're talking about, we're going to have
witnesses testify at the next panel. And incidentally, if
you've got a minute, if you can stick around and listen to what
they say, or have you already heard what they have to say?
Dr. Alving. I'd be happy to stick around.
Mr. Burton. OK, well, thank you very much for being here.
Well, we have 10 minutes before we conclude our first vote.
I think I probably ought to run over and vote and come back. I
really apologize for the mess we've got today. What you're
saying and doing is going to be recorded and passed onto my
colleagues, and it's very important. So I hope you'll bear with
me and stick around for a little bit. We'll be right back as
soon as the votes are taken.
[Recess.]
Mr. Burton. First of all, I want to apologize once again.
It's been a long day. But we want to get as much information
from this hearing as possible. So we're going to be here as
long as it takes.
We now have Adriane Fugh-Berman. Would you come to the
table, Dr. Fugh-Berman. And David Brownstein, Dr. Brownstein,
he's the director of Holistic Medicine. Ms. Carol Petersen,
pharmacist with the Women's International Pharmacy.
Ms. Fugh-Berman is the assistant professor of physiology
and biophysics at Georgetown Medical Center.
Ms. Vicki Reynolds, hormone replacement therapy patient,
Houston, TX. And Steven F. Hotze, Dr. Hotze, founder of the
Hotze Health and Wellness Center.
OK, we're going to start with Dr. Fugh-Berman. Since we
have a pretty large panel, we'd like to get to questions as
quickly as possible. So if you can keep your comments to 5 or 6
minutes, we'd really appreciate it, if it's possible. Thank
you.
STATEMENTS OF ADRIANE FUGH-BERMAN, M.D., ASSOCIATE PROFESSOR,
DEPARTMENT OF PHYSIOLOGY AND BIOPHYSICS, GEORGETOWN UNIVERSITY
SCHOOL OF MEDICINE; DAVID BROWNSTEIN, M.D., CENTER FOR HOLISTIC
MEDICINE; CAROL PETERSEN, MANAGING PHARMACIST, WOMEN'S
INTERNATIONAL PHARMACY; VICKI REYNOLDS, OWNER, TEXAS RELIANT
AIR-CONDITIONING AND HEATING, INC.; AND STEVEN F. HOTZE, M.D.,
HOTZE HEALTH AND WELLNESS CENTER
Dr. Fugh-Berman. Thank you, Mr. Chairman.
I'm here today representing the National Women's Health
Network, which is a consumer advocacy group that takes no money
from drug companies, medical device companies or dietary
supplement companies.
Sex hormones, including estrogen and testosterone, do
decline with age. But restoring hormone levels to youthful
levels has not restored youth in anyone. But it's quite an old
concept. It's actually more than 100 years old. Animal testicle
extracts used to be injected into men, and in the 1920's there
was a briefly popular operation in which slices of animal
testicles were actually inserted into men's scrota.
So the first promotion of hormones for rejuvenation was
first directed toward men. But in the last few decades, most of
the emphasis of hormones for sort of achieving youthfulness has
really been aimed at women. And hormones are very useful
therapies for many medical conditions, insulin, for example,
for diabetes. Estrogens are actually very, and different kinds
of estrogens are very useful for treating hot flashes. Hot
flashes and vaginal dryness are actually the only proven
benefits of hormone therapy, estrogen therapy at this point.
But unfortunately, hormones don't prevent aging, and
unfortunately, there is no such thing as a harmless hormone.
All hormones, including the hormones that we make within our
own bodies, have side effects. And claims that bioidentical,
natural or naturally occurring hormones are safer than
conventional hormones are not backed by science. I'm just going
to talk about estrogen today, just for time reasons. The three
estrogens that humans make are estriol, estradiol and estrone.
And these are the hormones that are touted by compounding
pharmacies and some alternative physicians as harmless
alternatives to conventional therapy.
So people may recommend estriol alone, estriol and
estradiol, which is called Bi-Est sometimes, or all three,
which are called Tri-Est. Sometimes they're combined with other
hormones. Synthesized versions of these hormones, and they are
synthesized, are identical to human versions. But just because
humans make a hormone doesn't mean that it's good for us. High
doses of insulin can kill you. High doses of adrenaline can
kill you. High doses of thyroid can kill you, even if they're
natural. And cortisol, which is an adrenal hormone that is
promoted on Dr. Hotze's site, for example, increases the risk
of osteoporosis, increases glucose levels and causes immune
suppression. It is, however, a mood elevator, so probably
people feel good as they're developing osteoporosis and
diabetes. [Laughter.]
I've said that even the hormones that we make within our
bodies are not harmless. There are many studies that show that
women who have naturally higher levels of estrone, estradiol,
and estriol, actually of estradiol and estrone in their bodies,
are at higher risk of breast cancer than women who have
naturally lower levels of these hormones. A meta-analysis, for
example, that was published in the Journal of the National
Cancer Institute in 2002 analyzed nine studies on the subject
and found that levels of estradiol, estrone, testosterone, DHEA
and other sex hormones were strongly associated with breast
cancer risk in postmenopausal women. So postmenopausal women
who had higher naturally occurring levels of these natural
hormones had higher breast cancer risk.
And more recent studies that have been done in 2003, 2004,
have also backed this up. Higher levels of testosterone are
also associated with higher breast cancer risk in women.
Natural hormone proponents believe that estriol decreases
breast cancer risk. And in contrast to other estrogens, does
not increase uterine cancer risk. This belief is based on
publications, every single one of them more than 30 years old
and all of them written by one guy, Henry Lemon. Lemon
theorized that estriol could be a useful treatment in
preventing and treating breast cancer. There's only one
commentary by a guy named Fallingstad that isn't written by
Lemon, and it quotes an unpublished study by Lemon that says
that Lemon successfully treated some cases of breast cancer
with estriol.
Even Henry Lemon never claimed that. Henry Lemon never
published a clinical study of estriol. There is some evidence,
he did have some evidence from cell cultures, high doses of
estriol in breast cancer cells in culture will decrease the
growth of cells. But this is true of every estrogen. Low doses
stimulate growth, high doses decrease growth. In fact, estrogen
used to be used as a treatment, high doses of estrogen. So
that's true of any estrogen, it does not evidence.
Henry Lemon never published a clinical study. He did,
however, publish a review on estriol in 1980 in which he
describes giving estriol to 24 women. Six of them had their
metastases grow. That's one quarter of the treated population.
So this experiment can hardly be considered a success in breast
cancer treatment. Two women also developed endometrial
hyperplasia, a precancerous condition to endometrial cancer. We
know that estrogen causes endometrial or uterine cancer. And 2
out of 24 subjects in this study did develop the precursor to
uterine cancer.
In the review that the author wrote, he still seems to be
enthusiastic about estriol. I have no idea why. But I think
it's really frightening that there are still people today who
think that his theory holds any water.
We actually have information on estriol. Estriol is a
perfectly decent treatment for hot flashes. And it's used in
Europe, it's a very commonly used hormone therapy in Europe.
It's been used for decades in England and Sweden and other
countries. It's a conventional treatment, sold by conventional
drug companies. And in conventional medicine in Europe, it was
thought that you didn't have to use it with a progestin to
protect the uterus because it's such as weak estrogen.
So there were many women who received estriol alone because
it was thought it was too weak to cause estrogen induced
uterine cancer. That turned out that to be wrong. We now know
that estriol is associated with endometrial hyperplasia and
endometrial cancer. Women who have ever used estriol, this is a
Swedish study, had twice the risk of endometrial cancer as
women who never used estriol, and 5 years worth of use of oral
estriol tripled the risk. The use of vaginal estriol did not
seem to be associated with an increased risk.
So this is less of a risk than with stronger estrogens, but
it still caused cancer in women. So nowadays, estriol is used
with a progestin in the same way that other estrogens are.
In terms of cardiovascular risk----
Mr. Burton. Excuse me, Doctor, if you could summarize. I
want to make sure we get to the questions. We have six people,
five people on the panel.
Dr. Fugh-Berman. OK. Then I won't cover the data on
cardiovascular risk.
There is no reason to think that the estrogens promoted by
compounding pharmacies protect against heart disease or stroke
because estradiol has actually been tested in trials. There has
been a randomized placebo controlled trial of estradiol and
natural bioidentical hormone in 664 women after a stroke, and
it did not protect against stroke. There is also another trial,
the Esprit trial, in more than 1,000 women with a previous
heart attack, estradiol did not protect against heart attack or
death.
So it's not true that only conjugated estrogens have been
tested in randomized controlled trials. So has estradiol.
So compounding pharmacies are uniquely unregulated, at
least with commercially available pharmaceuticals of the
quality of the preparations is regulated, that's not true of
those in compounding pharmacies.
And I'll just conclude by saying that human studies, and
they have all the references, show that naturally high levels
of estrone and estradiol are associated with breast cancer
risks. Estriol pills increase uterine cancer risk and estradiol
does not protect against heart disease or stroke.
And I just wanted to add one thing, Mr. Chairman. I'm very
sorry about your wife, and I agree with you that pharmaceutical
estrogens were really over-promoted inappropriately for really
dozens of years for things that they shouldn't have been used
for. And that they do contribute to increased breast cancer.
But the estrogens that are promoted by compounding pharmacies
are also very likely to increase the risk of breast cancer in
other women. Thank you.
[The prepared statement of Dr. Fugh-Berman follows:]
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Mr. Burton. Before we go to the next witness, who did you
say sponsors your foundation?
Dr. Fugh-Berman. I don't have a foundation. I'm an
associate professor of physiology at Georgetown University
School of Medicine.
Mr. Burton. Does Georgetown get any grants from NIH?
Dr. Fugh-Berman. Does Georgetown get any grants from NIH?
I'm sure there are researchers there who do. I do not.
Mr. Burton. Do you get any benefit from any of the
pharmaceutical companies or any of that?
Dr. Fugh-Berman. No. And if you're talking about my
consumer advocacy, the consumer advocacy group that I
represent, the National Women's Health Network, we also do not
get any NIH funding.
Mr. Burton. Where do you get your funding?
Dr. Fugh-Berman. Twenty-five dollar a year membership and
some foundation support.
Mr. Burton. What foundations?
Dr. Fugh-Berman. Private foundations not associated with
any drug companies.
Mr. Burton. Where do the foundations get their money?
Dr. Fugh-Berman. From their investment portfolios, I
assume.
Mr. Burton. Could you for the record give me a list of the
people that contribute to the foundation? I'd like to see where
the money comes from.
Dr. Fugh-Berman. I can give you a list of the foundation
funders of the organization.
Mr. Burton. That would be helpful. Thank you.
Dr. Brownstein.
Dr. Brownstein. Chairman Burton, I'm honored to be speaking
to you, and I bring you greetings from the Wolverine State.
Mr. Burton. Just north.
Dr. Brownstein. Many of us involved in holistic medicine
have gotten into it because of an ill family member or an
illness themselves. And I got involved in it just as your
interest seems to have been peaked in it from ill family
members because my father was very ill with heart disease.
I had wanted to be a doctor since I was a little child. And
I was conventionally trained in medical school, began a
conventional practice, was not interested in anything
alternative or holistic. I used to tell my patients, don't do
the alternative therapies, because I thought they were
worthless, even though I didn't know much about that. And I
would make derisive comments to them. I remember telling my
mother-in-law, don't take your vitamins, because I thought she
was wasting her money, which she never fails to remind me of
today.
However, all through medical school and post-medical school
and residence, my father was very ill with heart disease. He
had his first heart attack at 40, his second heart attack a few
years later. He had bypass surgeries in the midst of a number
of years. He had a couple of angioplasties. He had continual
angina for 25 years, cholesterol that was uncontrolled in the
300's or 400's on cholesterol lowering medications. He was
seeing the best doctors from the University of Michigan and
wasn't getting any better.
And I finished my residency, I'm in a busy conventional
practice. And a patient sees me and gives me a book, Healing
with Nutrition by Dr. Jonathan Wright. I took that book home,
wasn't much interested in it, but I flipped to the section on
cardiovascular disease, since my father was dying before my
eyes. He did not have long to live at that point. And Dr.
Wright talked about how he used natural hormones to treat heart
disease.
When I started pulling the literature on natural hormones
and heart disease, there was a plethora of literature on
testosterone and heart diseases dating back to the early
1900's, most of it out of Europe. And I became very interested
in that, and I checked my father and his testosterone level and
DHEA level and estrogen levels, and ended up putting my father
on three or four natural hormones, natural testosterone, DHEA,
natural progesterone and pregnenolone.
Within a matter of a week of putting him on these four
hormones, a 25 year history of angina resolved, never to
return. His cholesterol, which was stuck in the mid 300's, went
below 200, off cholesterol lowering medication. He lost weight,
he had a pale, sick looking face that now turned pink. His
friends and my mothers friends were asking what's going on with
him, he's looking so much better. He was able to walk around
without popping nitro pills all day. Once this conventional
physician saw the changes in my father with using natural
hormones, I decided that's what I wanted to do in medicine.
Since that point about 12 years ago, I have been
researching and utilizing natural hormones. And though I agree
with Dr. Fugh-Berman that there are a lot of problems with
estrogens in the environment, I think most of us men and women
are over-estrogenized. The problem isn't so much estrogen
deficiency, it's a hormonal imbalance, in part exacerbated by
estrogen excess. And the use of conventional hormones
exacerbates that and causes problems, like stroke, heart
disease, heart attacks, just as was found in the Women's Health
Initiative.
What I've found is that an imbalanced hormonal system leads
to chronic illness, such as auto-immune disorders, lupus, MS,
Hashimoto's, Grave's Diseases, the list can go on and on. It
leads to cancer, breast cancer, uterine cancer, ovarian cancer,
thyroid cancer, headaches, heart disease, the list goes on and
on.
And when somebody can get their hormonal system rebalanced
natural hormones, these conditions get markedly better. I see
it every day in my practice. Those of us that have used natural
hormones see the results in our patients and these items need
to be studied and they need to be kept available for patients.
As a physician, I want to be able to prescribe natural hormones
when they are indicated. We need the help of compounding
pharmacists to utilize these items.
My experience has been that most people with chronic
disorders have severely deficient levels of hormones when I
check them, including DHEA and pregnenolone and thyroid and
testosterone, with elevated estrogen levels present.
I'd like to just close by just explaining to you what a
normal hormone is. And I've got it in my handout, I wanted to
do a Power Point presentation, but I was told I wasn't able to
do it, although I would have my own projector.
Mr. Burton. If we had the other committee room. But we had
a big hearing there on scandal in Iraq. So we had to pass on
that.
Dr. Brownstein. Well, you don't even have to look at that
handout. Let me just explain to you in my mind what a natural
hormone is. The hormones work in our body in a lock and key
model. Just as you go out to your car door to start your car,
your key fits in your car door fine. If I put my key in your
car door, it's not going to fit quite right.
A natural hormone has the same structure as our own
hormones. So it's like the key that goes to find its lock. And
there are hormone receptors in our bones, our hearts, our
brain, our lungs. So when this key or this hormone goes to find
its receptor, it's like a perfect fit. It's like a perfect
puzzle fit.
When you use a synthetic hormone that's been altered, this
puzzle piece doesn't fit quite right. It's been altered. And
that's what I had for the slides to show you, just the
difference between the two. But this difference in this puzzle
piece not fitting quite right is what leads to the adverse
effects of synthetic hormones. And you just, as a practicing
physician, you just don't see the adverse effects with the
natural hormones that you do with the synthetic hormones. It
doesn't make sense to me to use something that doesn't fit
quite right in the body, when there is something available that
has a perfect fit.
[The prepared statement of Dr. Brownstein follows:]
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Mr. Burton. I want to talk to you after the hearing.
Dr. Brownstein. And I have some books for you that I'd like
to give you.
Mr. Burton. Well, don't give me too much to read. I have in
my office 9 million books. And although I read fairly fast, I
ain't going to get through them all. But I would like to talk
to you about that.
Ms. Petersen.
Ms. Petersen. Thank you, Chairman Burton. It's a pleasure
to be here.
I am one of the compounding pharmacists. I can speak for
thousands and thousands of patients and thousands of
practitioners throughout the United States. We have a quiet
revolution going on here in health care. People are no longer
accepting substandard care, and they're finding alternatives
and alternative practitioners such as Dr. Brownstein and Dr.
Hotze. It makes a huge difference in their lives.
I've been involved in this business since 1993, and
professionally and personally it's been the most rewarding
business of my whole life. People often ask us, where do these
hormones come from, when we talk about natural or bioidentical
hormones. Because they are identical to human, conceivably you
could think, well, maybe we squeeze these out of humans, and
certainly it could be done. In France for the longest time
their source of progesterone was human placenta, and they
extracted it from there.
But it's made semi-synthetically. Many plants have a
compound in their body made from cholesterol that is very, it's
in their body and it's similar to cholesterol in the human
body. This is the basis for all the steroidal hormones, like
estrogen, progesterone, testosterone, DHEA, cholesterol is.
From this plant nucleus that is similar to cholesterol, they
can make in the laboratory any of the hormones that you would
wish to have. You can make them chemically identical to human,
you can alter them and get a patent. For example, birth
controls are 100 percent synthetic, but also made from this
beginning plant material.
So the big difference is what it does in your body, just as
Dr. Brownstein had said. I'd like to say that the FDA has the
ability to authorize drugs in this country. And I believe that
they should have full power to do so when anybody wishes to
introduce into the general population something that is a brand
new chemical. Lord knows we have plenty of those. And I think
they don't regulate them as well as they should in many cases.
We don't reward manufacturers very well, there are some
ways around it, for instance the estrogen patches. The
companies have to obtain a patent on the patch, not the
hormone. I think if our medical industry took a positive stance
and looked for ways to be using these hormones in a positive
way, and some of them are, we'd end up much better.
The other really interesting thing about using bioidentical
hormones is I think reflected in some papers that were written
by a professor at the University of Washington. He wrote
several papers on N-1 studies. He believes that our current
gold standard of double blind placebo crossover studies are a
farce. You and I are not biochemically identical, you and I
aren't biochemically identical. If you participate in a study,
no matter how large, whatever you glean from there does not
apply to me as an individual. It never can. I am biochemically
unique.
So with N-1 studies, a certain protocol is embarked on with
a patient for a particular issue and it's done for a while, a
washout period maybe, another trial tried, until you find what
works best. And I submit that compounded bioidentical hormones
made for the individual and done in a clinical practice
satisfies this N-1 study. That's probably the only real
scientific, true scientific method for each individual.
Bioidentical hormones are very easy to track. You can test,
as Dr. Brownstein has mentioned, you can test in saliva, urine,
blood. It doesn't take a rocket scientist to figure out if
something is lower than normal. I'm not talking about higher
than normal, lower than normal. And you have symptoms of those
hormones being lower than normal. And you take those hormones
and you put it back in that patient, you can recheck
clinically, you can recheck blood saliva and urine, it's all
available now. And you can make a big difference for that
particular person's life. And I have heard it over and over and
over again, thank you for giving me back my life, thank you for
giving me back my brain, thank you for giving me back my wife.
And money can't buy what that kind of practice is.
[The prepared statement of Ms. Petersen follows:]
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Mr. Burton. I have some questions for you when we get to
how you determine what the level should be in each individual.
Ms. Reynolds.
Ms. Reynolds. I'm also very honored to be here, and I want
to thank you for your time, because I know your time is
important now.
Mr. Burton. That's fine. No more votes for another hour or
so.
Ms. Reynolds. After 40 years, 40 plus years of frustration,
exasperation and desperation, I finally had what I considered
at least now a quality of life, because of prescribed all
natural hormone replacement therapy. And my saga began at age
13, and I know that I speak for many women in America and many
of my friends who have suffered the same symptoms and the same
things that I have suffered. As a teenager, it began with
excessive pain, excessive bleeding that would last sometimes a
solid week, extreme pain and nausea and missing school.
This continued throughout my teen years. This continued on
up into my 20's. And after I married, I don't know if some of
the symptoms disappeared, or maybe you just get so busy that
maybe you put some of those symptoms behind you. But these
continued, these same symptoms continued. I went for my year
examinations as I thought I was supposed to. I would explain
each time, and I would go through these symptoms. And either I
got a shake of the head or I got, well, some women are just
that way. I thought, well, OK, so some women are just that way.
OK, so you go to another doctor and you explain your
symptoms and finally in your 30's, you tell them, you know, I
think I'm losing some of my hair. I only have half my eyebrows.
Do you think possibly maybe I have a problem? And they
prescribe things for you that then cause you to have other
things that they then have to prescribe something else on top
of that to counteract what they have already prescribed for
you, which causes you to have other problems, such as
dizziness, nausea and breaking out in rashes.
So then you decide, well, you know, I believe I could live
with what I was presently having rather than go into a whole
new realm of concerns for which I'm sure there would not be an
answer. So I thought, OK, I think I look forward to menopause,
because I bet all this will be behind me.
Well, of course, that's not the case. Once you hit
menopause, you have those symptoms you've carried over from
teenage years and your married life, and you've just about
killed everyone in your family. So then you get to move into
menopause with a whole new set of symptoms, of fatigue, of
dizziness, of nausea, of high fevers and you still are not
given answers to your problems, except that, well, you know you
are getting older. Well, yes, I know that I'm getting older.
But when I was here when I was 30, it was because some women
are just that way. Now suddenly it's because I'm just getting
older is why I'm having these symptoms.
So after being prescribed about six synthetic medications,
which each one gave me a new symptom with which I had to deal,
and of course, you don't know what to do except go back to your
doctor, who then gives you another prescription drug in order
to treat the new problem you've just acquired.
Well, when I went through a series of all of these where I
had other symptoms with which they were now going to give me
other prescription medications to treat those new symptoms, on
the last prescription drug I was given, which was the patch,
which caused a whole realm of new things that we could be all
day into the next vote on this one, so I'll just tell you that
I had several symptoms to deal with at that point. And the last
climactic symptom I had was severe migraine headaches that
lasted 3 days. And so when I called the doctor, and I noticed
that one of the side effects listed other than the fact that I
could die of a heart attack was also one of the side effects,
and that I could have dizzy spells. But in case I had severe
migraine headaches, do notify your physician.
I notified my physician. And my physician called me in a
prescription for the severe migraine headache, without saying,
oh, by the way, why don't you come in to see me. When I hung up
the phone and I realized he was just going to call me in a
prescription for something to cover that new symptom, I called
him back and I said, you don't want to see me, you don't want
to know why I'm having this headache? I believe there must be a
reason. He said, no, I don't need to see you, I have called you
in a prescription.
I said, and what is this prescription? And when he told me
the name of it, he said, it's the newest thing on the market
for treating severe migraine headaches. I said, oh, wonderful,
could you give me the name of some patients for whom you've
given this to that I might talk to them about what now this
might do to me? And he said, no, because it's so new I haven't
prescribed anyone this medication yet. I said, thank you so
much. Since you don't need to see me, I don't need to see you
again either.
At that point, I found a magazine article that talked about
Dr. Hotze's wellness center that treated with all natural
medications. I ended up there, and I ended up getting on all
natural hormone therapies, which I have yet to have a symptom
that I have to take something else for.
And I am well. I have energy, which we have more than just
night sweats when we go into menopause, ladies and gentlemen.
We have all kinds of things happen to us. And all of those
things are gone. I have energy. I feel good. I lost the 20
pounds that I gained during all this 40 plus years of battling
with this. And I am at least alive. My family can tolerate me.
I don't feel the need to strangle people at any moment, in some
cases. And I have a quality of life.
And I hope that this option is never taken from me.
[The prepared statement of Ms. Reynolds follows:]
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Mr. Burton. Thank you for that story. It's very, very
interesting. Do men get night sweats, too? [Laughter.]
Ms. Reynolds. They're contagious. [Laughter.]
Mr. Burton. Dr. Hotze.
Dr. Hotze. There is a solution for women in mid-life who
experience a host of health problems related to hormonal
decline and hormonal imbalances. The solution is natural,
biologically identical hormones. They are safe, they are
natural and they are effective.
As Vicki so articulately presented her history of problems
that she had, in our Health and Wellness Center in Houston, I
have seen thousands of women, we see 1,500 new guests every
year, we call our patients guests, they're not patients,
they're guests. We elevate treatment, we think doctors ought to
treat their customers as nicely as other businesses do. So we
take care of our guests when they come in.
And 35 percent fly in from across the country. They have
sought help in their local areas, New York, Los Angeles, and
they can't find physicians that will help them overcome their
problems. And their problems can be as simple as breast
tenderness, mood swings, fluid retention, weight gain and
headaches that may happen premenstrually, irregular menstrual
periods, breakthrough bleeding, depressed moods, premenstrual
and irritable moods.
Eventually, as Vicki mentions, as they move through their
menstrual life, their hormones begin to decline, particularly
progesterone. And what do they get? They get loss of energy,
they get weight gain, they begin to lose their hair. Their
eyebrows start to fall out, their hands are cold, they shiver,
they can't think clearly, they're irritable, they're depressed,
they're anxious, they get panic attacks, they go to bed, they
can't sleep. They channel surf all night long. We channel surf
during the day, they gripe at us. But at night, they channel
surf all night long because they can't get to sleep. They wake
up tired, they go to bed tired and they wake up tired. And they
often have to slug it out all week at work so they can get home
on Saturday so they can go to bed for 2 days so they can make
it through the next week.
They visit their physician and their physician runs a blood
test and says, everything is normal. And they go, I'm not
normal. Well, you're not normal, but I think there might be a
problem. You need a little antidepressant. And they'll put them
on Prozac and Effexor and Zoloft and a whole host of them and
completely ruin their lives. If they didn't have libido before
they start, though, they won't have any libido after that. If
they used to say, well, I don't think about sex, now they say,
I don't even care that I don't think about it any more when
they get on these drugs.
Then they get headaches, so they put them on the headache
medication and they put them on sleep medication and anti-
inflammatory medication and before you know it, these women,
their personalities have been completely changed, and then they
may try the birth control pills or the counterfeit hormones,
which cause a host of problems, as Dr. Alving so clearly told
us. The Women's Health Initiative clearly told us what has been
in the literature for over 14 years. Since 1989 there have been
five major studies that showed that the counterfeit hormones
are dangerous, they cause tremendous side effects.
And any physician that listens to a woman, the woman will
tell you, Doctor, these make me feel bad. And I say, if they
make you feel bad, don't take them. That's the best sign in the
world is how you're feeling. If your energy level is gone, you
gain weight, you don't think clearly, get off the stuff. My dad
used to tell me, and he wasn't a doctor, beware of doctors,
they will poison you to death with their drugs. And do you know
that the leading cause of death in America is not cancer, it's
not heart diseases, if you look at the facts, it's iatoragenic
illness, drug-induced illness from the drugs that doctors give
patients. It's the leading cause of death. You'll find it's the
third leading cause, but if you do the statistics, it's the
leading cause of death.
The drugs that the FDA approves kill Americans every day,
100,000 in the hospital every year. And these are drugs that
are given and prescribed by doctors and given in appropriate
doses in the hospital and it kills them. My suggestion is,
well, why do people get sick to begin with? Well, they get sick
because their hormones decline. Just like a diabetic young
person may get diabetes when their insulin declines. We would
never withhold insulin, we replenish insulin.
When your hormones, Congressman and Congresswoman and staff
members, begin to decline, you're going to begin to feel the
symptoms of the aging process. Yes, it's natural. Yes, it's
common. But it's not healthy. That's when you're going to get
heart disease, that's when you're going to get diabetes, that's
when you're going to get cancer, you're going to get arthritis.
What can you do to prevent that? You're not going to
prevent death, but you can sure improve the quality of life by
simply replenishing, in your body, replenishing in your body
the same hormones that your body used to make in adequate
amounts when you were younger. Keep them at a normal level.
And for gosh sakes, do not take the drugs that the drug
companies are putting out. Because they will kill you, and the
women's health study has said that, I've been saying that for
10 years. And I was out on the extreme when I said that 10 or
15 years ago on my radio programs and all over town. Well, Dr.
Hotze's a little out on a limb, he's saying these drugs are bad
for you.
Well, guess what? Now that it turns out I was right, did
they say Dr. Hotze was right? No, they went, well, we don't
want to bioidentical, let's just put them on some other drugs.
So we're going to go on Premarin light. You've heard of Miller
and Miller Lite. Dr. Alving told us that now they have offered
Prempro light. We'll kill you slower, not as fast as we would
have. You'll get cancer, it will take you twice as long to get
cancer. Then if that doesn't work, we'll just put you on drugs
and drug you up.
So ladies, if you start acting a little bit weird, and you
don't feel good and your doctor, most likely it's going to be a
man, and the way men look at women, he's going to look at you
and say, I just think you're a hypochondriac. But he's not
going to say that. He'll go, I think you might have a little
problem with depression. Ninety percent of the women between 35
and 55, 90 percent of the antidepressants that are prescribed
are prescribed to women. Why do doctors give women all the
antidepressants? Why don't the men get the antidepressants?
As to studies, there is a plethora of studies, and I would
be glad to forward these to the doctor at the end of the table,
who is an academician at a medical school and frankly, with all
due respect, should be ashamed that she hasn't read this
plethora of literature. I'll be glad, I'm the president of the
American Academy for Biologically Identical Hormone Therapy.
Dr. Fugh-Berman, I will be glad to forward you catalogs of all
this information that you can read and make up your own
decision. I'll be glad to send you that. And I will send you
that as soon as we get back to Houston. Then you can comment on
it after that.
In 1981, the Johns Hopkins Public School of Health did a
study published in the American Journal of Epidemiology, a 20
year study. It showed that there was one chemical in a woman,
when she lost the chemical, she had a 555 percent increase of
breast cancer and a 1,000 percent increase of death of all
kinds from cancer. And wouldn't it be nice if you knew what
that particular molecule was? The Johns Hopkins School of
Public Health determined when it was missing, that women had a
555 percent increase of breast cancer. Dr. Berman, do you know
what that was, have you read the article?
Dr. Fugh-Berman. Perhaps if you had included a reference in
your testimony, that would have been helpful.
Dr. Hotze. I did.
Dr. Fugh-Berman. It's also a epidemiological study, not a
randomized control trial, and I am extremely familiar with
hormones.
Mr. Burton. I don't want to lose control of the hearing.
[Laughter.]
Dr. Hotze. Anyway, the hormone was progesterone. So the
dramatic increase in risk factor for women getting cancer is
the decline in their progesterone levels and progesterone is a
naturally occurring hormone that women have and every cell in
their body requires it.
Finally, there is a solution for women's health problems in
mid-life and thereafter. When should a woman start taking
bioidentical hormone replacement therapy? As soon as she starts
having symptoms, which can happen, in the case of somebody like
Vicki, at 13. She may need just a little bit of progesterone.
But this is the solution, and this is safe and it's
effective. We have treated thousands of women. I have done
numerous clinical studies and presented them at medical
conferences. We are now training doctors, OB-GYNs in Houston,
TX. We are leading a wellness revolution that will change the
way mainstream medicine, and the way men and women in America
area treated in mid-life through the use of biologically
identical hormones.
And we thank you, Congressman Burton and you, Congresswoman
Watson, for your interest in alternative, safe, effective
alternatives for health problems. And this would save the
country billions of dollars. The last thing that people need
when they're older is all these drugs they drug them up with.
Why do you think sitting in a nursing home they drool and they
can't talk to you and
you go, Mama's losing her mind? They've got her drugged up on
anti-anxiety, anti-depressants and sleep medications. Get her
off the drugs, get her out of there, she's liable to be normal
again. I've seen this happen.
[The prepared statement of Dr. Hotze follows:]
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Mr. Burton. Thank you, Doctor.
Dr. Hotze. Thank you, sir.
Mr. Burton. The one thing I wish you could help me with is,
I'm a little bit older now and I've never understood women. And
if you could find some way to give me some kind of a hormone
replacement that would make me understand women. [Laughter.]
Dr. Brownstein, Dr. Fugh-Berman, I will have some questions
for you in a minute. But I have to tell you, after listening to
your testimony, it sounds remarkably similar to testimony we've
had from people who represent the pharmaceutical companies who
have been before me over 4 years. And that's why, and I don't
mean to impute your integrity at all, but that's why I asked
you where your funding was coming from and what the foundation
funding sources were.
Dr. Fugh-Berman. Could I respond?
Mr. Burton. Sure.
Dr. Fugh-Berman. I'm really flattered to be accused of
that, or even----
Mr. Burton. You're not accused.
Dr. Fugh-Berman. No, no, but I am really flattered, because
actually I do a lot of work against pharmaceutical companies.
And the National Women's Health Network does as well.
Pharmaceutical companies shudder when we come into FDA advisory
committee rooms. So yes, it's a novel position to be in.
But I just also wanted to say that actually, I have
practiced alternative medicine for many years. I was medical
director of two clinics in Washington, and I currently teach in
the only masters degree granting program in alternative
medicine in the United States at Georgetown, which we just
started last year. So I'm normally seen as a sort of nuts and
granola, herbs and dietary supplement person. So this is a very
interesting position for me to be in.
Mr. Burton. OK. Dr. Brownstein and Dr. Hotze, what I'd like
to know is, where is your practice, Dr. Brownstein?
Dr. Brownstein. Outside of Detroit.
Mr. Burton. You're outside of Detroit. Do you have people
come in, like Dr. Hotze, that stay for a while and you do a
battery of tests on them and then you decide what hormone
replacement therapy, natural hormone replacement therapy they
should take?
Dr. Brownstein. We have people come in from all over the
country and out of the country. We check levels before we
institute any hormonal therapy, pre and post. And we follow our
patients closely.
Mr. Burton. I was looking at your chart here. In the chart
there was a picture who looked like she was severely
overweight. And then it shows another picture right after that.
Is that the same lady?
Dr. Brownstein. That's the same lady with 6 months of
treatment with natural hormones.
Mr. Burton. Six months? How much weight did she lose?
Dr. Brownstein. About 75 pounds.
Mr. Burton. Was this without weight control?
Dr. Brownstein. She was a lady around 40 years old, had a
baby and fell apart during the pregnancy. And she had normal
blood tests for thyroid levels. When I put her on a small
amount of thyroid hormone plus a few natural hormones that were
imbalanced, her health recovered.
Mr. Burton. And she lost weight?
Dr. Brownstein. She lost that weight.
Mr. Burton. Without any dietary weight loss substances?
Dr. Brownstein. Took no dietary substances.
Dr. Fugh-Berman. Thyroid will make anyone lose weight.
Mr. Burton. Yes. Thank you, Dr. Berman.
[Simultaneous conversations.]
Dr. Hotze. That's not correct.
[Simultaneous conversations.]
Dr. Brownstein. That's not correct.
Mr. Burton. In any event----
Dr. Hotze. That's the difference between a clinician and an
academician.
Mr. Burton. Well, I don't want to get into a fight here.
I'm glad you're sitting at opposite ends of the table.
[Laughter.]
But what I'd like to----
Dr. Hotze. Well, we'll juice it up a little bit, because we
heard your hearings get pretty good.
Mr. Burton. Well, I've never been known to back way from a
fight. [Laughter.]
But in any event, what I'd like to know is, you've spoken
in generalities. She mentioned studies, clinical studies, that
sort of thing. Do you have any clinical studies or anything
that we could--and I don't want you to give me this much----
Dr. Hotze. Yes, sir, I do, and we will send you those. I
have clinical studies from my office, and I will send you the
clinical studies also that I promised you.
Mr. Burton. Has the FDA or HHS ever taken issue with you,
come into your office and----
Dr. Hotze. No. And they can't, because FDA has no authority
over the practice of medicine. That's all governed by the State
Board of Medical Examiners.
Mr. Burton. How about HHS or any of the health agencies?
Dr. Hotze. They have no authority over----
Mr. Burton. Have any of the State health agencies given you
a hard time?
Dr. Hotze. No.
Mr. Burton. The reason I ask is because, some people who
practice alternative modalities of medicine have had problems
with various Government agencies. And they literally put some
of them out of business.
Dr. Hotze. True, they do. Unfortunately, they pick on the
little ones that aren't strong. They will pick on people that
will back down. But they don't pick on us.
Mr. Burton. Got that. Ms. Petersen, how do you determine
through your pharmacy, how do you determine what substances
people need to take, hormone replacement, that will help make
them better?
Ms. Petersen. Actually, we don't. The practitioners do.
Mr. Burton. So you work with people like Dr. Brownstein and
Dr. Hotze?
Ms. Petersen. That's quite right. And as both doctors
referred to, there's really a plethora of information out
there. There's very much a lot of basic research in the fields
of endocrinology, physiology and even medicine that identify
what symptoms are related to what hormone. We know that from
those basic studies. And then we also have quite a bit of
literature on when you use a particular hormone, how much it
takes to get to normal blood levels. So there are ranges of
these hormones that are used.
And within that paradigm, knowing what clinical response
you expect to get, and what the usual dose ranges are and what
blood levels or saliva levels or urine levels you can
anticipate improving, with all those tools, the clinician is
very straightforward, very scientific to determine what people
need.
Mr. Burton. So what you do, Dr. Brownstein, Dr. Hotze, is
that you take blood tests, saliva tests, urine tests, and you
analyze those and you decide from those tests whether or not
there's a deficiency of certain hormones?
Dr. Hotze. First, everyone in this room, as you age, your
hormones are going to decline. There are scientific studies on
that. And women know that.
So the first thing we do, I do, I'm a clinician, the first
thing we do is take a copious 26 page history. The history
tells you everything. If you understand how the hormones work,
when a woman walks into your office, she's 38, she had a baby,
and now she's experiencing breakthrough bleeding and she's
experiencing mood swings, breast tenderness, you know she needs
progesterone.
Mr. Burton. Yes.
Dr. Hotze. So we don't draw a blood level on progesterone,
we will draw a blood level on thyroid and some of the other
hormones. But if a woman is menopausal, she's not making any
hormones, you don't have to check her blood for that, she's
already told you. So you replenish it in the average normal
range that is accepted and that relives the symptoms.
Mr. Burton. How do you determine that?
Dr. Hotze. Well, you do a physical exam.
Mr. Burton. Do you do diagnostic tests?
Dr. Hotze. Yes, we do tests. But if any woman in menopause
walks in, I can look at her and know what her size and weight
is, and she tells me her symptoms, I'm going to know the dosage
that she needs to take. And that's the starting dose. And then
we work, we see her back in followup and make adjustments.
Mr. Burton. How about you, Dr. Brownstein? Do you do it the
same way?
Dr. Brownstein. I check, as I said before, pre and post
levels in everyone.
Mr. Burton. How do you do that, through blood tests, saliva
tests, urine tests?
Dr. Brownstein. Blood and urine tests. And the idea of
being a physician is to put the whole picture together for the
patient, to look at their physical exam, look at their history,
look at their blood work and look at whatever other signs you
can come up with and then put the whole picture together, not
rely on one aspect only to treat people.
And when you look at the whole picture, I think you can get
a better treatment regimen together for somebody.
Mr. Burton. I see, and then you prescribe pretty much all
holistic hormonal replacements?
Dr. Brownstein. If someone has strep throat, I'll prescribe
penicillin. There is a place for drug therapies.
Mr. Burton. I know, but I'm talking about as far as the
deficiencies in people.
Dr. Brownstein. I will only prescribe natural hormones.
Mr. Burton. What about men? You've been talking a lot about
women.
Dr. Hotze. I'll speak specifically. Men also, as they age,
lose, their testosterone level declines. So a man at 40 will
have one-half the testosterone level he had in his 20's, at 50
a third, at 60 a quarter. Testosterone is essential. It affects
your initiative, your assertiveness, sense of well-being, self-
confidence, moods, goal orientation, your drive, direction,
decisiveness, analytical ability----
Mr. Burton. I feel sick already. [Laughter.]
Dr. Hotze. Your analytical ability, and we know this
because if a man loses his testicles from cancer or injury, he
has difficulty, he can't read a map, he can't think in three
dimensional terms.
Mr. Burton. But you treat----
Dr. Hotze. So when you give them testosterone, oh, my gosh,
it's huge, and I take it myself, and I have for 7 years. It's
remarkable.
Dr. Brownstein. Mr. Chairman, you mentioned that heart
disease, or somebody mentioned heart disease was the No. 1
killer in the United States. I have yet to see a patient with
severe heart disease have a normal testosterone level, man or
woman. They all have low levels. And when you look at the
literature on testosterone and heart disease, there is tons of
it. I have file cabinets at work of testosterone and heart
disease relationships.
Mr. Burton. So for men, you will check their testosterone
levels and you'll compensate?
Dr. Hotze. Prescribe, yes.
Dr. Brownstein. Check all their hormone levels, but yes,
testosterone is one of the things.
Mr. Burton. Ms. Watson.
Ms. Watson. I want to thank all the witnesses, and sorry to
be late coming in. We're always conflicted.
Dr. Hotze, I believe in holistic medicine. What do you see
are the problems today, when I say today, I mean today, in the
use of naturally occurring biological methods for addressing
the hormone loss? What is the problem? Is the problem with the
FDA?
Dr. Hotze. There is a potential coming problem with the
FDA. Pharmacies, just like medical doctors, are all governed
and regulated by their various State boards of pharmacy. The
FDA has recently tried to extend, and we believe illegally
attempted to extend its jurisdiction to govern pharmacies,
particularly compounding pharmacies. They have already issued a
compliance policy guideline that would prohibit compounding
pharmacies that make products for veterinarians where they
prohibit them from buying it in bulk. That's what their
compliance policy is, which has no force of law, but people
think it does, and they intimidate people.
Now, what they want to do, and all compounding pharmacies
buy their products in bulk from a pharmaceutical manufacturer,
whether their products are synthetic or whatever. Compounding
pharmacies don't just make bioidentical hormones, they make a
plethora of drugs based upon a doctor or pharmacist patient
relationship.
So the FDA wants now to restrict bulk use of ingredients in
that pharmacy. That shuts them down. They can't do it any more.
That's how you make a compounded product, you buy in bulk. They
will next move to humans and say, we're going to restrict you
doing this in humans, you can't buy the bulk product.
And then Vicki won't be able to get hormones any more,
because the way they want to control the doctors that are
practicing alternative medicines is shut down the compounding
pharmacies. That's their goal.
So what we would like to ask you, we need your help,
Congresswoman Watson and Chairman Burton. We need to ask you if
you would consider writing a letter to the FDA, asking them to
focus their efforts on tracking all these dangerous drugs from
the pharmaceutical companies, which they say they don't have
enough money to do, and leave the pharmacies under the
jurisdiction of the State boards of pharmacies, in other words,
stop the intervention. They are intimidating the little guys.
Now, I'm big enough, I can go out and hire a lawyer and
spend hundreds of thousands of dollars. I haven't had to do
this, but I've joined in coalitions that have fought the FDA.
I'm willing to do that. But a little guy on the corner can't do
it. And they're going to shut all the little people down.
Ms. Watson. Let me ask you, what is the FDA's position on
intervening? Do they feel that maybe the studies have not
been----
Dr. Hotze. They don't intervene on biologically identical--
they haven't intervened on biologically identical hormones.
They haven't done that. But they want to shut down compounding
pharmacies.
Ms. Watson. Why is this?
Dr. Hotze. Because, with all due respect to the FDA,
they're regulatory bureaucrats. Every regulatory agent wants to
control things. And when Kesler got into power, he wanted to
control dietary supplements. He wanted--you couldn't get a
vitamin unless you went to your doctor and your doctor wrote a
prescription.
What are the odds of your doctor writing you a prescription
for vitamins? In most people, they'll never do it, because when
my dad asked me, when he had heart disease in 1988, he said,
son, I read about vitamins, the doctor says I need to take
vitamins. He said, what do I take? I said, Dad, what the hell
do I know? I'm a doctor. I don't know anything about vitamins.
And he said, will you find out? And I did. That's how I got
into alternative medicine. Very similar story to Dr.
Brownstein's, my dad's heart disease and health problems got me
into alternative medicine.
Ms. Watson. Well, do they lean more toward the synthetics?
Dr. Hotze. Yes, of course. Yes, they do.
Ms. Watson. Is it to the benefit of the pharmaceutical
companies?
Dr. Hotze. Voila! If something doesn't seem logical, like,
you mean, I can get something, I can replenish my body with
water if I'm thirsty, but you want me to drink Coke when I'm
thirsty, but all I need, I'm dying in the desert and all I want
is water, and you're going to do a double blind study, well,
you're trying to sell me that Coke.
The same thing with the hormones. We have available, as we
age, the ability to replenish our hormones with the same
identical hormones your body used to make in adequate amounts.
Oh. But you can't patent those.
Dr. Fugh-Berman. Could I clarify something about
bioidentical hormones? This is important.
Bioidentical hormones are available in commercial
pharmaceutical preparations. Compounding pharmacies buy them
from drug companies. You can get 17 beta estradiol, the exact
bioidentical estrogen that is in our bodies, in patches, in
pills, in vaginal tablets, inc reams. Is that not correct?
Ms. Petersen. That's absolutely correct, it's only partial.
Dr. Hotze. It's partial.
Dr. Fugh-Berman. What is different? What is different in
the preparations that you use than in the commercially
available pharmaceutical versions of estrone, estradiol and
testosterone?
Ms. Petersen. I can tell you that in a minute. Say
prometreium progesterone comes in 100, 200 milligrams. I have
many, many people who use 10 milligrams, 15 milligrams, 50
milligrams, 250 milligrams. You cannot do it with a commercial
product and it's not appropriate for them.
Also the fillers and the binders in some things, our
pharmacy does a lot of work with environmentally sensitive
people. We pay attention to that. Commercial products are not
appropriate. There's dyes and fillers that will cause severe
reactions with them.
Dr. Brownstein. The other thing that Carol is pointing out
is that, all these therapies need to be individualized.
Ms. Petersen. Yes.
Dr. Brownstein. You require a different dose than the lady
next to you. And when you're relying on pharmaceutical
companies, they only have a couple of doses fits all size.
Ms. Watson. Let me just say this. I'm an example----
Mr. Burton. Hold on a second.
Dr. Fugh-Berman. We tailor medications in conventional
medicine. What my problem with this is not that these people
are too alternative, but that they're too conventional. These
are the same sorts of claims that were made without data by the
company that made Premarin.
Mr. Burton. Would you yield?
Ms. Watson. I'll yield to the Chair.
Mr. Burton. Let me just say this. As we age, and I know
you're very young, we take a lot of pills. Can you imagine me
breaking these pills apart and trying to see? You can't do
that. You'd go crazy first of all, and you'd probably kill
yourself.
I think what Drs. Brownstein and Hotze are trying to say is
that this is going to be, they're going to try to find out what
your deficiencies are and tailor it to the individual. And a
one size fits all commodity coming out of a pharmaceutical
company won't cut it.
Dr. Fugh-Berman. Right. And it's fine to tailor therapy. We
do that in conventional medicine, we do it in alternative
medicine, and I consider myself a practitioner of both.
Mr. Burton. Well, my doctors don't.
Dr. Fugh-Berman. But the idea that there are known normal
levels of all hormones is actually not true. That we don't know
what the normal age levels are of, for example, estrogen. You
cannot tell from blood levels of estrogen who's having hot
flashes and who isn't. So blood levels of 20 year olds are
higher in estrogen than blood levels of 70 year olds, but you
can't tell who's having hot flashes, you don't know what a
normal level of estrogen in a 70 year old is.
So this is an aura of science over something that is not
scientific. Also saliva is not an appropriate, salivary hormone
tests are not appropriate for several hormones, including
progesterone, and that's been shown in scientific studies.
Ms. Watson. Can I get my time back? [Laughter.]
Mr. Burton. Ms. Petersen, do you want to respond real
quick, and then it's back to my good buddy.
Ms. Petersen. I did. It's like looking at one thing, and
none of the practitioners look at an estradiol level without
looking at the clinical picture. Some women normally have very
high estrogen levels throughout their whole lifetime. And when
they drop, they may not drop very much, but they notice a huge
difference. You have to tie the two.
You can't rely on a test, and I agree, saliva tests are not
the best tests. And there is some possibility of its use for
some diagnostics, but not across the board. I agree entirely.
It's just a tool. You can't just use one tool. You can't take a
saliva test, no matter how good the test, or the blood test,
and you can't figure out how many milligrams of this or that
will do it for you. It's trial and error. You have to work with
the patient and the clinical response.
Dr. Hotze. And that's scientific. That's the history of
medicine. Evaluate, make a diagnosis. Start on preparation of
medications, see how the guest or the patient does. Make
adjustments. That's scientific. That's the science of medicine.
Ms. Watson. Dr. Fugh-Berman, I wasn't here for all the
testimony, so let me direct this to you. In describing the
condition of my own health, I have difficulty with patent
medicines. I have side effects, and I have to continue to
change. I use holistic medicine most often, because it has been
customized to my own system. I can't take anything harsh and I
usually have to break down prescriptions because they're just
too strong for my system.
Can you explain what problems you might have with seeking
the natural hormones that are customized and will help an
individual? I find that in patent medicine, there are so many
additives, and I remember my doctor said, read labels. So I
read labels on everything. When I see the additives, I know I'm
going to be in trouble. And I'm trying to find the right kinds
of foods that will go with my system. I don't know if that's a
hormonal thing or not. But as I age I become more and more
allergic to almost everything.
So can you describe for me why you think the natural kinds
of hormonal treatments are not as good as the others?
Dr. Fugh-Berman. I wouldn't actually say that. I would say
that the use of estriol, Bi-Est, Tri-Est or commercially
available pharmaceutical preparations are effective for hot
flashes and vaginal dryness. Those are the only things that
they have been proven to be effective for.
It's important to individualize any of these medications to
a woman, especially now that we know that estrogens don't
provide other health benefits, and that they do provide risks.
However, there is no evidence that natural bioidentical
hormones, whether they are in pharmaceutical drugs or in
compounded prescriptions, are safer than synthetic estrogens.
Ms. Watson. You said there is no evidence?
Dr. Fugh-Berman. There is evidence that they are----
Ms. Watson. Hold on. How do we gather evidence?
Dr. Fugh-Berman. From observational studies or randomized
controlled trials. We have randomized controlled trials showing
that estradiol increases stroke risk. We have information from
epidemiological studies that estriol increases endometrial
cancer risk.
This is not an unknown. This is known, and it's consistent
with what we know about other estrogens. In my testimony, while
you were away, I pointed out that even higher levels of
naturally occurring estrogens in our own body are actually
associated with higher levels of breast cancer risk. So there's
no such thing as a harmless hormone. Hormones have risks.
Sometimes it's worth it taking those risks for somebody who
has very severe hot flashes, taking a risk of a slightly
increased chance of having breast cancer might be worth it. But
there is no evidence that these have other health benefits and
it's really bothersome to me as a public health physician, as a
physician concerned about public health, that there are claims
being made that these compounded prescriptions will increase
quality of life or prevent any disease. There is no evidence to
support that, and there is evidence to support that they are
harmful.
Ms. Watson. I heard you say twice there is no evidence. And
it would seem to me that if we did short term and long term
studies across the board, maybe it would yield some empirical
evidence that then we can base claims on both sides on.
I would think, and in my own case, as I said, I chose to go
to a holistic provider because the patent medicines were not
helping me. I was becoming allergic to them.
So would you not agree that we need to go into the studies
and try using these hormones beyond just the hot flashes and
the dryness in the uterus? Would you not agree that we really
need to do some studies to see in what levels, in what dosages
and so on they could or could not work?
Dr. Fugh-Berman. You know, for many years, the medical
profession thought that hormones were going to be helpful.
Ms. Watson. No, no, no, no. Let me direct--my time is
getting short. Let me get you on point.
Dr. Fugh-Berman. There have been studies already done about
these natural hormones.
Ms. Watson. But I thought you said there was no evidence,
no empirical evidence.
Dr. Fugh-Berman. No. I said that there are randomized
controlled trials showing that estradiol increases stroke risk.
Ms. Watson. OK, time.
Dr. Fugh-Berman. They're referenced in my written
testimony.
Ms. Watson. Dr. Fugh-Berman, what would you have against,
starting today, I think it's July 22nd, going forward to do
some in-depth kinds of studies to see about the effects of
using these natural hormones and customizing them to the
individual? Would you be, as an educator, as a clinician, as a
doctor, would you be against that kind of research?
Dr. Fugh-Berman. It depends on what the indications were
for, Congresswoman Watson.
Ms. Watson. Will you write a hypothesis----
Dr. Fugh-Berman. There already have been studies of estriol
for hot flashes and bone. It helps them.
Ms. Watson. Hold on. I was very clear in giving you a date.
And I----
Dr. Fugh-Berman. What's the position you're studying?
Ms. Watson. Well, that's your hypothesis, you know. And I
have a Ph.D in education, I don't have one in medicine. But I
do know how you formulate a study. What I'm saying to you is,
would you have, would you object to studies going forward? Not
what they've already done, but going forward to then be able to
present empirical evidence?
Now, let me tell you, I've been in this business of making
policy for many, many years. For 17 years, I headed up the
health and human services committee in the State Senate in
California. We decided many years ago that smoking was bad for
your health. So I came in with proposals, and I would have to
convince my own colleagues that we ought to look and do
research. They laughed, and they said, oh, no, and they were
looking at the tobacco industry and protecting them and so on.
So I found that education was the thing. And it took us 14
years, but we were the first State that prohibited smoking in
California air space, and now it's pretty universal. So I know
what it takes to educate, when you make policy, that does no
harm and does the best good.
And so I would think that you've got tremendously
compelling arguments on the other side, and I hear you kind of
stuck in what was. I'm wondering if you could be flexible to
see what could be.
Dr. Fugh-Berman. I wouldn't be against doing long term
studies with a reasonable hypothesis. However, it's generally
considered unethical to study a drug with no proven benefit
when we have evidence of harm.
Ms. Watson. That is why you do a hypothesis. You make a
proposal. And I also established bioethics committees in every
hospital in the State of California, because we were having
problems with the HMO movement and so on.
So I was, what I wanted to hear from, and anyone can
response to this, maybe Dr. Brownstein, would you feel that it
was ethical to start doing some short and long term studies to
be able to determine with empirical evidence if this was an
effective kind of treatment?
Dr. Brownstein. Well, certainly we need to do studies and
answer as many questions as we can. I would agree with Dr.
Berman, I think estrogens are a major problem in the
environment. They're in pesticides, they're fattening up the
animals with estrogens, they're in plastics. The natural
estrogens are the least of any natural hormone that I use. I
don't use them in most women, I don't use them in men. And I
use a lot of the other natural hormones to reverse or improve
people's health and help them get over their chronic illness.
Dr. Hotze. And Congresswoman Watson, I have already
initiated studies, and there are a lot of clinical studies. In
fact, the PEPI study, which was completed in 1995, which is the
Postmenopausal Estrogen Progestin Intervention study, and I
think that was Government funded as well, first line of
treatment for women on estrogen therapy, postmenopausal, the
first line of treatment they said they needed natural
progesterone first. But very few doctors prescribe natural
progesterone, they all prescribe the counterfeit--provera,
medroxyprogesterone and the other counterfeits, because that's
what the drug companies sell.
The drug companies can't patent anything biologically
identical. They can't do it. You can patent the strength or the
formula, but you can't patent the hormone. There's no money in
it for the drug companies. That's the way it is.
If there's no money in it, they're not going to promote it.
And that's why we in private practice, like Dr. Brownstein and
myself and hundreds and thousands of other doctors across the
country and compounding pharmacists have embraced, we've seen
what it's done to our patients, and I would say for Dr. Berman,
I would be glad to offer her a one person test, I invite you to
come to our office in Houston, be worked up, be evaluated, do a
2-month trial and see how you feel.
Dr. Fugh-Berman. Thank you. That would save me $3,000.
Dr. Hotze. Yes, it would, it would save you that. I'd be
glad to. Then you could do it from personal experience, see how
you feel and then talk about it. Because I've been on both
sides of the aisle. I was over on your side of the aisle at one
time, too. But I decided to challenge it, think out of the box,
think unconventionally. And believe it or not, the world would
always be the same if people never thought out of the box and
thought conventionally. Thank God you all didn't.
Congresswoman Watson, if you hadn't been willing to
challenge the tobacco industry and everybody said, you're crazy
as you can be----
Ms. Watson. Do you know what my last proposal to my
colleagues was? I was commissioning the University of
California to research the connection between wrinkling and
smoking. Well, the guys almost laughed me off the floor.
Dr. Hotze. And they're doing it now probably.
Ms. Watson. The bill passed. Three years later, they came
back and made the connection and the rest is history.
Dr. Hotze. There you go. And of course, Congressman Burton
too, with the mercury problem.
Mr. Burton. I thought you were going to talk about my
wrinkles. [Laughter.]
Go ahead, I'm just kidding.
Dr. Hotze. But you thought out of the box and challenged
the conventional thinking on mercury, both of you have. And to
your credit. That's wonderful. Thank God for you all being
willing to do that. And that's what we need, people in the
medical community to challenge it. All you have to do is listen
to women and the way they're treated and how they feel and
they're not being taken care of.
There's a revolution coming. The doctors in this room and
across the country, they don't even know it's coming. But there
are going to be women like Vicki Reynolds that go, Doctor,
guess what, I'm firing you, good-bye, click.
Mr. Burton. In any event, what I'd like to do, because it's
getting late and some of you have to catch planes and so forth,
I'd like to have your recommendations on what we can do to make
holistic medicine and these complementary and alternative
therapies more available and also, any information you have on
the safety of them and the efficacy of them.
Dr. Hotze. I will send you that.
Mr. Burton. We would like to have that.
And you said something about a letter earlier.
Dr. Hotze. A letter to the FDA. And if I could have your
permission to visit with one of your staff members----
Mr. Burton. Yes. I think Mindi and Brian, Brian is my right
arm in the office. Brian and Mindi will be happy to sit down
with you and talk with you about that.
Dr. Hotze. Thank you very much.
Ms. Petersen. Chairman Burton, if I might say something.
Mr. Burton. Sure.
Ms. Petersen. I would like to propose that we have a money
back guarantee.
Mr. Burton. What?
Ms. Petersen. A money back guarantee.
Mr. Burton. On what?
Ms. Petersen. On health care. If you go to your doctor and
he doesn't get you healthy and that prescription you got
doesn't make you better, money back.
Mr. Burton. You know, I want to tell you, that's a very
interesting statement. We have 600 lobbyists in Washington that
represent the pharmaceutical industry, 600. There's 535 Members
of Congress and the Senate. They outnumber us. And any time we
talk about, Congresswoman Watson and myself, or anybody else
talks about anything, you would not believe the attacks and
everything else that takes place.
Just to give you a little aside, so you'll know why I'm
saying that what you're talking about is crazy, because it's
never going to happen, is that in Canada, a woman who buys
tamoxifen can buy it for $50, $60, and it's a very big help for
women that have had cancer. In the United States, it costs as
much as $350 for a 30 day supply. And yet the Food and Drug
Administration and the pharmaceutical companies and everybody
else have said, oh, my gosh, we don't want reimportation. And
they come up with a million reasons why we can't have it.
That's just one example. There are hundreds and hundreds
and hundreds of pharmaceutical products that cost four, five,
six, seven times as much here as they do elsewhere. And yet the
pharmaceutical companies have been fighting like crazy to stop
reimportation. They are a very, very powerful lobby. And
doctors, I think a lot of doctors probably would not be aware
of a lot of things, so I'm not sure they're going to give you a
money back guarantee on things they're not aware of, so I don't
think that's going to happen.
In any event, I would like to have from you, including you,
Dr. Fugh-Berman, I'd like to have any recommendations that you
have that you think we could utilize to help the health of
women. And don't forget the men. You haven't talked much about
the men today, and you know, I'm getting up there, I'd kind of
like to know how I can be more virile and keep my hair and keep
the color down. So if you have any testosterone with you, throw
a couple packages up here for me before you leave. [Laughter.]
In any event, thank you all for being here. Did you have
any other questions, Ms. Watson?
Ms. Watson. No, thank you, Mr. Chairman.
Mr. Burton. But I would like to have anything you think we
should be doing in writing, so we can followup on it, because
we will do that.
Thank you very much. We stand adjourned.
[Whereupon, at 5:35 p.m., the subcommittee was adjourned,
to reconvene at the call of the Chair.]
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